PMA P040012S042

Device: RX ACCULINK CAROTID STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P040012
Supplement: S042
Product code: NIM
Decision date: 2012-03-29
Generic name: Stent, carotid
Approval order statement: APPROVAL FOR ADDITION OF THE EMBOSHIELD FAMILY OF EMBOLIC PROTECTION SYSTEMS (EPS) TO THE STANDARD RISK INDICATION AND AN UPDATE TO THE MAGNETIC RESONANCE COMPATIBILITY SECTION OF THE LABELING.

Current openFDA PMA Record#

Device: RX ACCULINK CAROTID STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P040012
Supplement: S042
Product code: NIM
Generic name: Stent, carotid
Decision date: 2012-03-29
Decision code: APPR
Date received: 2011-09-19
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR ADDITION OF THE EMBOSHIELD FAMILY OF EMBOLIC PROTECTION SYSTEMS (EPS) TO THE STANDARD RISK INDICATION AND AN UPDATE TO THE MAGNETIC RESONANCE COMPATIBILITY SECTION OF THE LABELING.